FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450436936
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K12-07972A
Published
2026-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OEQAngiography/angioplasty kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEQAngiography/Angioplasty KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450436933PackageGS125In Commercial Distribution
20884450436930PackageGS14In Commercial Distribution
00884450436936PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445043693310884450436933
2088445043693020884450436930
00884450436936008844504369368844504369360884450436936

Regulatory Flags#

DUNS number
184763290
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450148174Merit Medical®Initial ReleaseK09-09012A2026-10-31
00884450428061Merit Medical®Initial ReleaseK10-01518B2026-10-31
00884450499191Merit MAK™GMAK401N-E2026-10-30
00884450499221Merit MAK™GMAK401N2026-10-30
00884450499245Merit MAK™FMAK501N2026-10-30
00884450499870Merit S-MAK™FS-MAK501N2026-10-30
00884450500033Merit Medical®Initial ReleaseK09-05053T2026-10-30
00884450839362Prelude Roadster™APG8F45SX2026-10-30
00884450254677Merit Medical®Initial ReleaseK12-082752026-10-29
00884450838129Prelude Roadster™APG6F45MP2026-10-29
10884450708443Prelude®FPSI-7F-11-035-18G2026-10-29
00884450429150Merit Medical®Initial ReleaseK12-11133A2026-10-27
00884450436677Merit Medical®Initial ReleaseK09-10693C2026-10-27
00884450456286ReSolve®GRBDC-10-0382026-10-27
00884450838105Prelude Roadster™APG5F45S2026-10-03
00884450838143Prelude Roadster™APG6F45S2026-09-03
00884450838204Prelude Roadster™APG7F45S2026-09-02
00884450839119Prelude Roadster™APG5F45R2026-10-03
00884450839126Prelude Roadster™APG6F65MP2026-09-03
00884450839133Prelude Roadster™APG6F65S2026-06-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS19657A0Aligned Medical SolutionsAligned Medical SolutionsOEQ2026-11-02
B098AMS202330Aligned Medical SolutionsAligned Medical SolutionsOEQ2026-10-30
00884450254677Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-29
10198956560505CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956568075CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956586154CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956588646CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956590052CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956610682CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956611221CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956615342CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956618640CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956618725CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956619630CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956619852CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956620254CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956620261CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956621336CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956622418CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956622425CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
00884450429150Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-27
10809160541814Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OEQ2026-10-27
10198956605091CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-26
10198956607590CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-26
10198956610873CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-26
10198956620322CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-26
10198956106666CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956530157CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956563063CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956590229CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23